Knee PainNCT00752765
The Effects of Bariatric Surgery Weight Loss on Knee Pain in Patients With Osteoarthritis of the Knee
An observational study of Knee Pain and Knee Osteoarthritis, run by Penn State University at 1 site in United States.
Trial summary
This project is a prospective observational study that will involve the participation of 25 volunteers that qualify for having knee osteoarthritis, are going to be having gastric bypass surgery and are willing to participate in this study which is designed to last up to two years. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Pain, Knee Osteoarthritis
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Sep 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study will be looking at obese patients with co-morbidity of knee osteoarthritis.
Who may be able to join
- To be included in the study, patients must be between the 18 and 70 years of age
- Completed a pre-surgery psychological evaluation, and have had intermittent knee pain for at least a year.
- The bariatric surgery requirement involves a bypass of the stomach.
- Standard of care guidelines for this surgery require that these patients' previous dieting attempts were without success
- Medical problems related to obesity, such as diabetes, sleep apnea, hypoventilation, and joint pain.
- Patients will have a WOMAC pain scale score > 3, according to the study by Miller, et al.
- Patients will have a standing AP, lateral and Merchant radiographic scan taken to confirm that they have OA.
Who cannot join
- Patients will be ineligible for the study if any of these criteria are not met.
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17070
About this study
This project is a prospective observational study that will involve the participation of 25 volunteers that qualify for having knee osteoarthritis, are going to be having gastric bypass surgery and are willing to participate in this study which is designed to last up to two years. Potential candidates will be interviewed using a standard set of questions related to the study
Read the detailed description
Osteoarthritis (OA) of the knee is one of the five leading causes of disability among elderly men and women1. According to the American Academy of Orthopedic Surgeons, an estimated 19 million visits are made each year to physician's offices due to knee-related problems, while the total cost of OA was estimated at $60 billion in 2004.2
Obesity is a primary risk factor for the development of OA among several other features such as age, gender, trauma, infection, heredity, and high impact sports. In the United States, obesity has reached epidemic proportions and experiments have shown that individuals clinically defined as obese with a BMI > 30.0 kg/m2 are four times more likely to have knee OA than those with a BMI < 25.0 kg/m2(3).
The most common non-surgical treatment for knee OA has been the use of non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs work by inhibiting the cyclooxygenase (COX) enzymes involved in the production of pro-inflammatory molecules in the body. Although the use of these drugs has been shown to temporarily relieve pain and swelling associated with OA, there are several negative side-effects related to NSAID use including health concerns and cost.
If chronic NSAID use for knee pain can be reduced, that would be an exceptional public health benefit and would decrease cost and related hospital admissions and deaths.
This study investigates a non-surgical approach to the relief of pain associated with osteoarthritis in an attempt to offer a safer, less expensive alternative to other treatments.
In this study we will be examining the effect of weight loss through bariatric surgery on Knee pain in patients with clinical criteria indicative of osteoarthritis.
Our main objective is to determine if weight loss from bariatric surgery contributes to relief of knee pain and increased function in patients with osteoarthritis.
The study will be looking at obese patients with co-morbidity of knee osteoarthritis.
An interview will be administered and if appropriate, potential candidates will be asked a series of questions taken from the pain section of the Western Ontario McMaster Universities Index of Osteoarthritis (WOMAC). Patients with a WOMAC pain score ≥ 3 will then be asked to have a series of X-rays taken of their knees. Those individuals who display radiographic evidence of knee OA will be asked to participate in the study until the twenty five positions are filled. At their next pre-bariatric surgery visit, the study participants will have a basic knee exam performed by Kevin P. Black, M.D. in order to evaluate the structural integrity and alignment of the knee joint. The information gathered from the exam will serve as a baseline measure of knee function for the study. Prior to undergoing surgery, each of the 25 patients will be asked to complete a full version of the WOMAC survey and a separate, related survey the Knee and Osteoarthritis Outcome Score (KOOS). These surveys will be re-administered at 6, 12, and 24 months post-surgery in order to assess any changes in knee pain and function.
- Conditions
- Knee Pain, Knee Osteoarthritis
- Keywords
- knee osteoarthritis, bariatric surgery, weight loss, knee pain
- Medical subject headings
- Osteoarthritis, Knee, Weight Loss
What is being measured
The primary outcome is the main question the study is designed to answer.
Outcome measures will be determined with the WOMAC and KOOS surveys.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Knee PainStudies of the same condition, open and under way.
- More trials run by Penn State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kevin P. Black, Penn State University
- Investigators
- Ann M. Rogers, M.D., Study director, Penn State Milton S. Hershey Medical Center, Dept of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00752765
- Sponsor's protocol ID
- 28727
- Status last verified
- May 2012
- First submitted
- 11 Sep 2008
- Last updated
- 3 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
1. Osteoarthritis of the Knee: State of the Condition. American Academy of Orthopedic Surgeons. 2004. http://www.aaos.org/Research/documents/oainfo_knee.asp.
Buckwalter JA, Saltzman C, Brown T. The impact of osteoarthritis: implications for research. Clin Orthop Relat Res. 2004 Oct;(427 Suppl):S6-15. doi: 10.1097/01.blo.0000143938.30681.9d.
PubMed 15480076Miller GD, Nicklas BJ, Davis C, Loeser RF, Lenchik L, Messier SP. Intensive weight loss program improves physical function in older obese adults with knee osteoarthritis. Obesity (Silver Spring). 2006 Jul;14(7):1219-30. doi: 10.1038/oby.2006.139.
PubMed 16899803Banthin, J. S. and Zodet, M. Trends in the Use and Expenditures for COX-2 Inhibitors and Traditional Nonsteroidal Anti-inflammatory Drugs, 1997-2003. Statistical Brief #139. September 2006. Agency for Healthcare Research and Quality, Rockville, Md. http://www.meps.ahrq.gov/papers/st139/stat139.
Blower AL, Brooks A, Fenn GC, Hill A, Pearce MY, Morant S, Bardhan KD. Emergency admissions for upper gastrointestinal disease and their relation to NSAID use. Aliment Pharmacol Ther. 1997 Apr;11(2):283-91. doi: 10.1046/j.1365-2036.1997.d01-604.x.
PubMed 9146764Graham GG, Graham RI, Day RO. Comparative analgesia, cardiovascular and renal effects of celecoxib, rofecoxib and acetaminophen (paracetamol). Curr Pharm Des. 2002;8(12):1063-75. doi: 10.2174/1381612023394917.
PubMed 11945151Aw TJ, Haas SJ, Liew D, Krum H. Meta-analysis of cyclooxygenase-2 inhibitors and their effects on blood pressure. Arch Intern Med. 2005 Mar 14;165(5):490-6. doi: 10.1001/archinte.165.5.IOI50013. Epub 2005 Feb 14.
PubMed 15710786
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Bariatric Surgery Weight Loss on Knee Pain in Patients With Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT00752765
- Acronym / sponsor ID
- 28727
- Conditions
- Knee Pain, Knee Osteoarthritis
- Keywords
- knee osteoarthritis, bariatric surgery, weight loss, knee pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 15 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project is a prospective observational study that will involve the participation of 25 volunteers that qualify for having knee osteoarthritis, are going to be having gastric bypass surgery and are willing to participate in this study which is designed to last up to two years. Potential candidates will be interviewed using a standard set of questions related to the study
Detailed description
Osteoarthritis (OA) of the knee is one of the five leading causes of disability among elderly men and women1. According to the American Academy of Orthopedic Surgeons, an estimated 19 million visits are made each year to physician's offices due to knee-related problems, while the total cost of OA was estimated at $60 billion in 2004.2
Obesity is a primary risk factor for the development of OA among several other features such as age, gender, trauma, infection, heredity, and high impact sports. In the United States, obesity has reached epidemic proportions and experiments have shown that individuals clinically defined as obese with a BMI > 30.0 kg/m2 are four times more likely to have knee OA than those with a BMI < 25.0 kg/m2(3).
The most common non-surgical treatment for knee OA has been the use of non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs work by inhibiting the cyclooxygenase (COX) enzymes involved in the production of pro-inflammatory molecules in the body. Although the use of these drugs has been shown to temporarily relieve pain and swelling associated with OA, there are several negative side-effects related to NSAID use including health concerns and cost.
If chronic NSAID use for knee pain can be reduced, that would be an exceptional public health benefit and would decrease cost and related hospital admissions and deaths.
This study investigates a non-surgical approach to the relief of pain associated with osteoarthritis in an attempt to offer a safer, less expensive alternative to other treatments.
In this study we will be examining the effect of weight loss through bariatric surgery on Knee pain in patients with clinical criteria indicative of osteoarthritis.
Our main objective is to determine if weight loss from bariatric surgery contributes to relief of knee pain and increased function in patients with osteoarthritis.
The study will be looking at obese patients with co-morbidity of knee osteoarthritis.
An interview will be administered and if appropriate, potential candidates will be asked a series of questions taken from the pain section of the Western Ontario McMaster Universities Index of Osteoarthritis (WOMAC). Patients with a WOMAC pain score ≥ 3 will then be asked to have a series of X-rays taken of their knees. Those individuals who display radiographic evidence of knee OA will be asked to participate in the study until the twenty five positions are filled. At their next pre-bariatric surgery visit, the study participants will have a basic knee exam performed by Kevin P. Black, M.D. in order to evaluate the structural integrity and alignment of the knee joint. The information gathered from the exam will serve as a baseline measure of knee function for the study. Prior to undergoing surgery, each of the 25 patients will be asked to complete a full version of the WOMAC survey and a separate, related survey the Knee and Osteoarthritis Outcome Score (KOOS). These surveys will be re-administered at 6, 12, and 24 months post-surgery in order to assess any changes in knee pain and function.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study will be looking at obese patients with co-morbidity of knee osteoarthritis.
Key inclusion criteria (7 listed)
- To be included in the study, patients must be between the 18 and 70 years of age
- Completed a pre-surgery psychological evaluation, and have had intermittent knee pain for at least a year.
- The bariatric surgery requirement involves a bypass of the stomach.
- Standard of care guidelines for this surgery require that these patients' previous dieting attempts were without success
- Medical problems related to obesity, such as diabetes, sleep apnea, hypoventilation, and joint pain.
Key exclusion criteria (1 listed)
- Patients will be ineligible for the study if any of these criteria are not met.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Outcome measures will be determined with the WOMAC and KOOS surveys.
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2015.
- Background1. Osteoarthritis of the Knee: State of the Condition. American Academy of Orthopedic Surgeons. 2004. http://www.aaos.org/Research/documents/oainfo_knee.asp.
- Background: PubMed 15480076Buckwalter JA, Saltzman C, Brown T. The impact of osteoarthritis: implications for research. Clin Orthop Relat Res. 2004 Oct;(427 Suppl):S6-15. doi: 10.1097/01.blo.0000143938.30681.9d.
- Background: PubMed 16899803Miller GD, Nicklas BJ, Davis C, Loeser RF, Lenchik L, Messier SP. Intensive weight loss program improves physical function in older obese adults with knee osteoarthritis. Obesity (Silver Spring). 2006 Jul;14(7):1219-30. doi: 10.1038/oby.2006.139.
- BackgroundBanthin, J. S. and Zodet, M. Trends in the Use and Expenditures for COX-2 Inhibitors and Traditional Nonsteroidal Anti-inflammatory Drugs, 1997-2003. Statistical Brief #139. September 2006. Agency for Healthcare Research and Quality, Rockville, Md. http://www.meps.ahrq.gov/papers/st139/stat139.
- Background: PubMed 9146764Blower AL, Brooks A, Fenn GC, Hill A, Pearce MY, Morant S, Bardhan KD. Emergency admissions for upper gastrointestinal disease and their relation to NSAID use. Aliment Pharmacol Ther. 1997 Apr;11(2):283-91. doi: 10.1046/j.1365-2036.1997.d01-604.x.
- Background: PubMed 11945151Graham GG, Graham RI, Day RO. Comparative analgesia, cardiovascular and renal effects of celecoxib, rofecoxib and acetaminophen (paracetamol). Curr Pharm Des. 2002;8(12):1063-75. doi: 10.2174/1381612023394917.
- Background: PubMed 15710786Aw TJ, Haas SJ, Liew D, Krum H. Meta-analysis of cyclooxygenase-2 inhibitors and their effects on blood pressure. Arch Intern Med. 2005 Mar 14;165(5):490-6. doi: 10.1001/archinte.165.5.IOI50013. Epub 2005 Feb 14.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ann M. Rogers, M.D. study director
Penn State Milton S. Hershey Medical Center, Dept of Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Pain and Knee Osteoarthritis, run by Penn State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Outcome measures will be determined with the WOMAC and KOOS surveys. (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00752765, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2015.